Cardiac Catheterization in Cardiac Arrest

Not Applicable

• Conditions: Out of Hospital Cardiac Arrest
• Interventions: Procedure: Cardiac catheterization

• Registration Number: NCT02587494
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

This is a pilot study that will lead to a large randomized control trial (RCT), to assess whether early versus late or no cardiac catheterization is associated with improved outcomes in out-of-hospital cardiac arrest (OHCA) patients.

Detailed Description

A pilot multicenter RCT.

The objectives of the study are:

To assess whether early (within 12 hours) cardiac catheterization is associated with improved survival, neurologic and cardiovascular outcomes in OHCA patients.

Patients will be randomized 1:1 to early cardiac catheterization, performed as early as possible, within 12h post return of spontaneous circulation (ROSC) following OHCA, or to standard practice, which may include medical management without cardiac catheterization or late cardiac catheterization after completion of therapeutic hypothermia. Percutaneous coronary intervention (PCI) is recommended for culprit lesions found on diagnostic angiography. All patients will undergo therapeutic hypothermia started as soon as possible with target temperature below 36°C according to local practice. Other medical management will be according to standard of care

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-08-27
• Study First Submitted QC: 2015-10-26
• Study First Posted: 2015-10-27
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-22
• Last Update Posted: 2017-08-23
• Study Start: 2017-12
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Glasgow Coma Scale score <8 on hospital admission following OHCA of presumed cardiac cause.
• Initial rhythm ventricular tachycardia (VT) / ventricular fibrillation (VF), who achieved ROSC sustained for >20 consecutive minutes

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Exclusion Criteria

• ST-elevation on any of the ECGs post resuscitation
• Hypothermia <30°C
• Interval from ROSC to screening of >12h
• Suspected or known acute intracranial hemorrhage or stroke

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early cardiac catheterization	Cardiac catheterization	Cardiac catheterization performed as early as possible, within 12h post ROSC following OHCA, with possible PCI during mild therapeutic hypothermia or apyrexia

Primary Outcome Measures

Name	Time	Method
Composite of death and poor neurologic outcomes ( Cerebral Performance Category [CPC] score 3-5).	30 days

Secondary Outcome Measures

Name	Time	Method
Composite of death and poor neurologic outcome	1 year
Death	30 day
CPC score	up to 30 days
Bleeding - according to Hb levels	30 days	Number of participant with overt bleeding according to Academic Research Consortium criteria
Stent thrombosis by pathology or angiography	30 days	Number of participants with definite stent thrombosis confirmed by angiography or pathology according to the Academic research consortium criteria
Acute kidney injury- creatinine levels	48 hours	Number of participants with increase in serum creatinine of ≥44.2 μmol/L, or a 25% relative rise in creatinine, within 48 h after contrast exposure42
Myocardial infarction - according to cardiac troponin levels	30 days	Number of participants with myocardial infarction post percutaneous coronary interventions, in accordance with the universal definition of myocardial infarction.
Stroke - imaging or pathology	30 days	New stroke following hypothermia confirmed by imaging (computer tomography or magnetic resonance imaging)
Heart failure (NYHA 3-4)	30 days
Estimated cost per patient according to length of stay and procedures performed	30 days

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada